1. Field of the Invention
The present invention relates to a prosthesis for hernia repair. In particular, the present invention relates to a prosthesis for hernia repair configured to protect a cord passing through the prosthesis, such as the spermatic cord when the prosthesis is employed in an inguinal hernia repair.
2. Discussion of Related Art
Various prosthetic materials have been proposed to reinforce the abdominal wall and to close abdominal wall defects. In certain procedures, the prosthetic fabric may come into contact with sensitive tissue or organs potentially leading to postoperative adhesions between the mesh and the sensitive tissue or organs. There has been a suggestion that, in an inguinal hernia repair, the prosthetic fabric may come into direct contact with the spermatic cord. Postoperative adhesions between the mesh and the spermatic cord and/or erosion of the mesh into the cord, were they to occur, could potentially affect spermatic cord structure and function. For example, tissue ingrowth could potentially result in infertility, pain or other detrimental effects due to strangulation of the spermatic cord.
Uzzo et al., xe2x80x9cThe Effects of Mesh Bioprosthesis on the Spermatic Cord Structures: A Preliminary Report in a Canine Modelxe2x80x9d, The Journal of Urology, Vol. 161, April 1999, pp. 1344-1349, suggests that the interposition of autologous fat between the mesh and the cord during open inguinal repair may prove beneficial. It had been proposed in U.S. Pat. No. 5,593,441, assigned to C.R. Bard, Inc., also the assignee of the present application, to repair ventral hernias and/or reconstruct chest walls using a prosthesis that is covered with an adhesion resistant barrier, such as a sheet of expanded PTFE. In the repair of ventral hernias and in chest wall reconstruction, the composite is positioned with the barrier relative to the region of potential adhesion, such as the abdominal viscera. Other configurations of composite prostheses can be found in U.S. Pat. Nos. 5,725,577 and 5,743,917, both of which are also assigned to C.R Bard, Inc.
International Publication No. WO 97/35533, by the present Applicant and also assigned to C.R. Bard, Inc., proposed a universal composite prosthesis in which one side of a layer of mesh material is completely covered with a layer of barrier material. The mesh material promotes biological tissue ingrowth while the barrier material retards biological tissue adherence thereto. The prosthesis may be utilized for various surgical procedures, including ventral hernia repair and inguinal hernia repair.
It is an object of the present invention to provide an improved method and prosthesis for the repair of hernias.
The present invention is a prosthesis and a method for mending a tissue or muscle wall defect, and has particular application in inguinal canal repairs near the spermatic cord. The prosthesis comprises a layer of repair fabric having a cord opening therethrough that is adapted to receive a cord-like structure, such as the spermatic cord, when the prosthesis is implanted at the repair site. The prosthesis also includes a cord protector that is attachable to the repair fabric at the cord opening to isolate the cord-like structure from at least the fabric in proximity to the cord opening. The repair fabric may be formed from a material which is susceptible to the formation of adhesions with sensitive tissue and organs. The cord protector may be formed from material which inhibits the formation of adhesions with sensitive tissue and organs.
In one embodiment of the invention, the repair fabric includes first and second surfaces and an opening having an edge that is defined by a portion of the layer of repair fabric. The cord protector covers a substantial portion of the edge to isolate the substantial portion of the edge from the cord-like structure.
In another embodiment of the invention, a layer of mesh fabric has a keyhole opening therethrough, and the cord protector extends about the keyhole opening and overlaps a portion of the layer of mesh fabric on opposing first and second surfaces thereof at least proximate the keyhole opening. The cord protector is adapted to receive the cord-like structure therethrough so that the layer of fabric is isolated from the cord-like structure by the cord protector at least proximate the keyhole opening.
The cord protecting material may extend away from the opening edge on the first surface and/or the second surface of the repair fabric. Additionally, the cord protector may extend substantially farther away from the opening edge on one of the first and second surfaces than on the other of the first and second surfaces. Further, the cord protector may substantially cover one of the first and second surfaces.
The prosthesis may be provided as a composite in which the cord protector is preattached to the repair fabric. Alternatively, the cord protector may be configured as an insert that is separate from and attachable to a prosthesis by a surgeon. This allows a surgeon to either retrofit a barrier-less inguinal hernia prosthesis or to employ an implantable repair fabric that may have various tissue or muscle wall defect repair applications.
In a further embodiment of the invention, a cord protector is provided for use with a hernia prosthesis having a cord opening therethrough that is adapted to receive a cord-like structure. The cord protector includes a cord protecting insert that inhibits the formation of adhesions with sensitive tissue and organs. The cord protecting insert is constructed and arranged to be attached to at least a portion of the opening edge of the opening edge to isolate the cord-like structure from at least the opening edge of the hernia prosthesis.
The cord protecting insert may include a backbone member. The cord protecting insert may include a flexible tube having a slot along a length thereof that is adapted to receive a portion of the hernia prosthesis along the cord opening.
Other objects and features of the invention will become apparent from the following detailed description when taken in conjunction with the accompanying drawings. It is to be understood that the drawings are designed for the purpose of illustration only and are not intended as a definition of the limits of the invention.